Cyrano Therapeutics has reported positive top line data from its Phase II FLAVOR clinical trial evaluating CYR-064, an intranasal soft-mist spray developed for persistent post-viral loss of smell, known as hyposmia.
The double-blind, placebo-controlled, randomised trial enrolled 151 patients across 14 clinical sites in the US with hyposmia, persisting at least six months.
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The study met its primary objective, showing that CYR-064 was safe and well tolerated, with no treatment-related serious adverse events recorded.
Durable improvements in smell function were observed across multiple prespecified secondary efficacy endpoints.
Cyrano Therapeutics plans to present comprehensive data at a medical conference in 2026.
Cyrano Therapeutics president and CEO Rick Geoffrion said: “This is the first randomised, controlled trial to show a pharmaceutical agent can safely improve smell function in patients with persistent post-viral hyposmia.
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By GlobalData“Once a person has lost their sense of smell for as long as six months, the chances become extremely small that their sense of smell will return. Also, when the sense of smell is lost, people also lose up to 80% of their perception of taste.
“So, in general, we are talking about the impairment of as many as two out of the main five human senses. CYR-064 has the potential to be the first approved therapy for millions suffering from this serious condition, one with no effective treatment today.”
CYR-064 is an intranasal formulation containing a broad-spectrum phosphodiesterase inhibitor and a targeted delivery system to enhance olfactory neuron excitability.
Hyposmia is recognised as a chronic sensory disorder following viral infection. It frequently impairs both smell and taste, limiting quality of life and increasing risks, including cognitive decline, mortality, and safety issues in older adults.
